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Chacruna.net is a hub for producing and disseminating high-quality multimedia content about plant medicines and psychedelics, facilitating access to these resources online. The website’s central objective is to offer content created and curated by leading experts in the field, edited to a wider audience. The field of psychedelics is filled with misinformation, anecdotal narratives, poorly trained professionals and enthusiasts with no field experience, leading discussions with large audiences of novices to the subject.

Casey Alexander Paleos, MD, is a Clinical Assistant Professor of Psychiatry at the NYU School of Medicine. He is currently serving as a Co-Principal Investigator for the MAPS-sponsored MDMA-Assisted Psychotherapy for PTSD Phase 3 clinical trial.

On Treading Lightly Through the Lion’s Den: The Path to Psychedelic Legitimacy

Casey Alexander Paleos, MD, is a Clinical Assistant Professor of Psychiatry at the NYU School of Medicine. He is currently serving as a Co-Principal Investigator for the MAPS-sponsored MDMA-Assisted Psychotherapy for PTSD Phase 3 clinical trial.

“turn on, tune in, drop out” provoked a conservative backlash of such ferocity that our society is still reeling from it

As the Western world approaches the dawning of a psychedelic
renaissance, it would be wise to pause for a look back at our history, if we
hope to avoid the doom of repeating it. While it’s not fair to hold Timothy
Leary wholly accountable for the reaction that the psychedelic movement of the
1960s elicited from the dominant culture of its time—he was, in the final
analysis, more the movement’s lightning rod than its architect—we cannot
overlook the outcome of his attempt to lead a full-frontal assault on the existing
power structure, which was frankly disastrous. His rallying cry urging
Americans to “turn on, tune in, drop out” provoked a conservative backlash of
such ferocity that our society is still reeling from it: Nixon famously
identified Leary as “the most dangerous man in America,” declared the War on
Drugs, and enacted the prohibition of psychedelics via the Controlled
Substances Act of 1970. Just like that, the most powerful tools for
psychotherapeutic healing and consciousness exploration known to humankind were
driven out of public reach into the underground, where they have remained, by
and large, for almost half a century.

Yet, for all that, the most valuable treasure to spill out
of the Pandora’s box of 1960s counterculture was not lost. Many people were
permanently and fundamentally transformed by the encounter with sacred and
transcendent dimensions of human experience afforded to them by these
substances. They did not lose sight of the importance of preserving, for their
fellow beings, the possibility of this encounter, the capacity for this kind of
transformation. Instead of ceding defeat, they chose to learn from the movement’s
failures, to forge different paths through a landscape grown so much more
foreboding than before; slowly, doggedly back to the promise of a society that
permits the exploration of personal divinity through these uniquely powerful
means.

Timothy Leary. Hindsight is 20/20.

One of these people is Rick Doblin, who, three decades after founding MAPS at the height of the Reagan administration and “Just say no”hysteria, has led the efforts of a small group of thoughtful, committed citizens to the cusp of something truly incredible: restoring the legitimacy of psychedelics in the eyes of the dominant culture, by demonstrating the safety and effectiveness of their use in a medical context. He did so by recognizing that long-lasting societal change of this magnitude cannot be imposed from without, as Leary sought to do; it can only be accomplished from within. He educated himself on the slow, stodgy channels of public policy change extant within the labyrinths of entrenched power, and, against all odds, found a way to successfully navigate them.

As a psychiatrist and clinical researcher who has seen and
experienced the profound healing potential of these substances, I am deeply
indebted to Rick and to MAPS for these efforts. They have provided me with
tools to achieve not the mere abatement of symptoms—which is the best that
traditional psychiatric medications can hope to accomplish, when they work at
all—but to effect true healing. It is hard to overstate the magnitude of the
unmet need for effective treatments in the field of mental health care: suicide
rates in the U.S. are currently the highest they have been in 30 years, and
there are hundreds of millions of people suffering from deadly illnesses like
major depression, drug and alcohol addiction, and PTSD, for whom conventional
treatments have proven completely ineffective.

While it is by no means a panacea, psychedelic-assisted
psychotherapy for these conditions, even in cases previously considered
intractable, has shown incredible effectiveness, approaching in many cases that
of a cure. I have seen this with my own eyes, through my work with both
psilocybin and MDMA. And herein lies the real tragedy, because it is hard to
imagine where the field of psychiatry would be right now, had the psychedelic
research that began to blossom in the 1950s not been truncated by the end of
the 1960s; had Leary, in other words, adopted an approach subtler than storming
into the lion’s den and poking the biggest cats he could find in the eye. How
many lives ravaged by suicide, addiction, and violence could have been saved? How
much suffering alleviated, or prevented?

This lost opportunity is a flood of tears, to be sure, but
it is water under the bridge all the same. Our task now is to move forward, and
try to help the many millions of people who can still be helped. Surmounting
the considerable hurdle of decriminalization and FDA approval is just the first
step. Our real task lies further ahead, and it is formidable. To address a
public health need of this magnitude requires an enormous infrastructure, which
will cost hundreds of millions of dollars to implement. The reality is that it
is well beyond the means of a non-profit organization like MAPS, reliant on
charitable donations for its daily operations, to establish this kind of
infrastructure, let alone operate it sustainably.

The reality is that, outside of a tax-funded government
agency—an unlikely champion of psychedelic use, to say the least—a for-profit
company is the only kind of organization capable of operating on this scale. In
other words, for an organization to be capable of reliably delivering a
high-quality, complex service such as psychedelic-assisted psychotherapy to many
thousands of people over the course of many years, it must be capable of sustainably
generating enough of its own revenue to provide for the training and salaries
of hundreds of providers and support staff, maintenance of facilities,
acquisition and storage of medicine, and so on. Charitable donations simply
aren’t going to cut it.

Never catch a leopard by the tail (especially if she looks like this).

In the case of MPBC, 100% of its profits are committed to its chosen public benefit, namely the furtherance of psychedelic research

This is, in fact why, in anticipation of conducting the
Phase 3 clinical trials that will hopefully result in FDA approval for
MDMA-assisted therapy, MAPS established its wholly-owned subsidiary, the MAPS
Public Benefit Corporation, or MPBC. To be clear, a public benefit corporation is
defined as a for-profit company whose establishing charter formally commits a
substantial portion of the revenue it generates toward a specific public
benefit. In the case of MPBC, 100% of its profits are committed to its chosen
public benefit, namely the furtherance of psychedelic research. More recently,
another for-profit corporation called COMPASS Pathways has entered the
psychedelic arena, and is gearing up to conduct Phase 3 clinical trials,
seeking approval from the FDA and its European equivalent, the EMA, for
psilocybin-assisted therapy for treatment-resistant depression.

These developments, particularly the entry of COMPASS into the field, have generated a lot of controversy in the psychedelic community; this was a hot-button issue at the conference Cultural and Political Perspectives in Psychedelic Science, recently held in San Francisco. Some have argued that for-profit companies are structured to place the private interests of their shareholders above those of the public and as such, are inherently corrupt; hence their involvement in this work can only result in the down fall of the psychedelic movement. Now, I am certainly not here to deny the existence of corrupt and unethical business practices, still less to defend them, nor amI here to sing the praises of capitalism; I am aware of the ways in which it fosters inequality and injustice, encourages the exploitation of natural and human resources, and concentrates power in the hands of a privileged minority. I am as fervently opposed to these tendencies as much as anyone with a healthy conscience ought to be.

But I must also live in the real world, as we all do, and
operate within the limitations of reality as it is presented to me, even as I
seek to improve the conditions giving rise to those limitations. And the
reality we all live in is that, unless you’ve decided to live completely off
the grid, grow your own food, weave your own fabric, smelt your own metal, and
so on—in which case, kudos to you, but how are you even reading this
article?—then you regularly rely on for-profit companies for at least some of
the goods and services required to sustain life in the modern world. Until we
can find a better way, these are the only means by which private citizens can
get things done on a large scale. Furthermore, the presupposition that a
company cannot be run both ethically and profitably is frankly untrue; to
insist otherwise precludes a rational discourse on the subject at hand.

More to the point, our present-day reality is that, outside
of the very small number of people exposed to the therapeutic use of
psychedelics in clinical trials, anyone likely to put themselves in a position
to have a powerfully transformative psychedelic experience is, in one way or
another, already on the fringes of society. This is the effect of the criminalization
of these substances, and these will continue to be the prevailing conditions
until psychedelics are decriminalized and made available to the mainstream for
widespread use, in a manner that is readily accessible, safe, and therapeutic.

And here is the real crux of the issue, and the question I
have for those who oppose the mainstreaming of psychedelics and the establishment
of the revenue-generating infrastructure that this will inevitably require:
what is your alternative? How else do you propose to deliver this treatment in
a manner that is safe, reliable, and affordable to the millions of people in
need of it?

To me, opposing the entry of for-profit organizations into
the psychedelic landscape is to be in favor of perpetually restricting access
to psychedelics for all but a tiny fraction of the population using them in
marginalized or underground contexts. This is a position I find ethically
unacceptable.

I will concede that the decision made by COMPASS to ignore the example set by MPBC and refuse to sign The Statement on Open Science is troubling. I would also argue that too much is being made of it. A full examination of the facts supporting this argument is outside the scope of this essay; suffice it to say that all important aspects of the technique used in psychedelic-assisted psychotherapy, not to mention the psychedelic molecules themselves, are already in the public domain. Furthermore, the need for this treatment is unfortunately so vast that no single organization, no matter how well-funded, could possibly crowd out its competition.

To my mind, the growth of a for-profit industry around the delivery of psychedelic-assisted therapy is not the cause for fear and lamentation that some have made it out to be

To my mind, the growth of a for-profit industry around the
delivery of psychedelic-assisted therapy is not the cause for fear and
lamentation that some have made it out to be. Rather, it is a marker of the
tremendous success the psychedelic movement has had in restoring legitimacy to
the use of these extraordinary tools for healing and the exploration of human
potential, and represents the solid ground this movement must have underneath
it to have any hope of creating the changes this world so desperately needs.

Help support Chacruna's team by being a sponsor

Chacruna.net is a hub for producing and disseminating high-quality multimedia content about plant medicines and psychedelics, facilitating access to these resources online. The website's central objective is to offer content created and curated by leading experts in the field, edited to a wider audience. The field of psychedelics is filled with misinformation, anecdotal narratives, poorly trained professionals and enthusiasts with no field experience, leading discussions with large audiences of novices to the subject.